Percutaneous access

ABSTRACT

Medical devices and related methods enable physicians and/or other medical personnel to access percutaneously the interior of a patient. One particular device includes a housing which defines a cavity, a first opening into the cavity, and a second opening into the cavity. The housing is implantable in a patient. The cavity is placed subcutaneously within the patient. The first opening is substantially flush with the surface of the skin of the patient and creates a percutaneous passageway from the exterior of the skin of the patient into the cavity, and the second opening creates a passageway from the cavity into the interior of the patient. A connector is coupled to the second opening and disposed substantially within the cavity to enable a connection between a first device and a second device disposed within the interior of the patient.

TECHNICAL FIELD

[0001] The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.

BACKGROUND INFORMATION

[0002] Long term access to a patient's bloodstream (longer than onemonth, for example) is required for many medical treatments includingantibiotic therapy, hemodialysis access, chemotherapy regimens, andother treatments that require repeated infusion or blood processing. Insome cases, internal access to the patient is required for years.Current devices and methods generally negatively impact the quality ofthe patient's life, and the patient sometimes develops complications asa result of the long term access. Vascular access devices used forlonger term treatments include tunneled central catheters (includingdialysis catheters), implanted infusion ports (including dialysisports), dialysis grafts, and fistulas. A cuffed catheter can be used fornon-vascular access, such as to the abdominal cavity for peritonealdialysis to prevent infection.

[0003] Tunneled catheters can cause infection of the bloodstream orperitoneum and the skin entry site. The external portion of the cathetercan fracture or otherwise fail due to its movement after placement.Also, the placed catheter can be accidentally or intentionally removedfrom the body, causing the patient pain and other complications. Thereis also the possibility of increased wear, damage, or disassembly causedby the patient “playing with” the placed device. The skin entry siterequires constant maintenance and clamps are required to preventbleeding through the catheter and to prevent air embolus. The portion ofthe catheter external to the patient's body frequently is uncomfortablefor the patient. The external catheter and the skin entry site canprevent the patient from bathing normally or engaging in normal physicalactivities.

[0004] Subcutaneously implanted access ports require the use of needlesto access the port through the patient's skin. Using needles, such asthe large needles used for dialysis ports, creates the potential forinfection and causes the patient pain. The access port reservoir has thepotential of accumulating debris and harboring infection. In the eventan internally-connected catheter connecting to this type of port needsto be replaced, a surgical procedure is required.

[0005] Grafts and fistulas on the patient's arm are disfiguring, andthey require frequent access with large bore needles which causes painand eventually destroys the access route. Grafts and fistulas alsorequire invasive vascular surgery to be created and revised.Additionally, interluminal declotting is often necessary.

[0006] With respect to medical devices that are permanently implantedinto a patient, such as a pacemaker for example, access is limited tosurgical means in order to reach the device to replace batteries orrepair components. Electrical leads that pass through the skin to supplypower and control for the internally-implanted device can causeinfection.

SUMMARY OF THE INVENTION

[0007] The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.In one embodiment, an access device allows physicians and other medicalpersonnel to obtain long term percutaneous access to a patient's body.The access device reduces the opportunity for infection by completelyshielding fluid connections (that extend into the interior of thepatient's body) from the patient's skin and from the externalenvironment. The access device has no protruding external elements, andcan be protected by a low-profile cover that is substantially flush withthe patient's skin. The access device thus is cosmetically appealing andallows substantially normal physical activity. The cover is difficult toremove accidentally or intentional from the access device. The accessdevice allows access to the interior of the patient without requiring aneedle to pierce the skin. Further, internal components, such as acatheter or a valve, can be replaced without a surgical procedure.

[0008] In one aspect, the invention involves a medical device. Themedical device includes a housing defining a cavity, a first openinginto the cavity, and a second opening into the cavity. The housing isimplantable in a patient to dispose the cavity subcutaneously within thepatient. The first opening is substantially flush with the surface ofthe skin of the patient and creates a percutaneous passageway from theexterior of the skin of the patient into the cavity. The second openingcreates a passageway from the cavity into the interior of the patient.The medical device further includes a connector coupled to the secondopening and disposed substantially within the cavity and allows for aconnection between a first device and a second device disposed withinthe interior of the patient. In one embodiment, the housing defines aflange for extending subcutaneously into the patient to anchor thehousing in the patient.

[0009] In another embodiment, the medical device further includes acover that is removably couplable to the housing. The cover selectivelyseals and exposes the first opening and is cover substantially coplanarwith the surface of the skin of the patient when sealing the firstopening. The cover is removable to allow the first and second devices tobe connected via the connector. The cover includes a locking mechanismto prevent the cover from being inadvertently removed. In otherembodiments the cover is canoe or elliptically shaped. In oneembodiment, the cover further includes an electrical connector. Inanother embodiment, the cover further includes a display.

[0010] In yet another embodiment, the connector includes a luerconnector. In other embodiments, the medical device further includes avalve. In still other embodiments, the medical device further includes acap removably coupled to the luer connector to selectively seal andexpose the luer connector. The cap removably couples to the luerconnector with a threaded connection. In some embodiments, the luerconnector is telescopic and capable of being extended out of the cavitywhen the cover is removed from the first opening. In other embodiments,the luer connector includes a pivoting luer connector which opens afluid path through the second opening when pivoted to a first positionand seals the fluid path through the second opening when pivoted to asecond position. In yet another embodiment, the connector includes anelectrical connector. In another embodiment, the connector is releasablycouplable to the second opening.

[0011] In still another embodiment, the first device includes aconnection tube and the second device includes a catheter. The catheterincludes a single lumen catheter a multilumen catheter.

[0012] In one embodiment, the first device includes an infusion devicefor infusing medication into the patient. In another embodiment, thefirst device includes a device for removing bodily fluids of thepatient. In still another embodiment, the first device includes a devicefor removing, purifying, and reintroducing blood into the patient.

[0013] In another embodiment, the connector includes anelectrical-connector. In one embodiment, the electrical connector isreleasably couplable to a battery disposable entirely within the cavityfor supplying power to the second device. In another embodiment, theelectrical connector is releasably couplable to a control devicedisposable entirely within the cavity for supplying control signals tothe second device.

[0014] In another aspect, the invention relates to a method of obtainingpercutaneous access to the interior of a patient. The method includesmaking a straight incision in the patient and implanting in the patientthrough the straight incision a medical device. The medical deviceincludes a housing defining a cavity, a first opening into the cavity,and a second opening into the cavity. The housing is implantable in apatient to dispose the cavity subcutaneously within the patient. Thefirst opening is substantially flush with the surface of the skin of thepatient and creates a percutaneous passageway from the exterior of theskin of the patient into the cavity. The second opening creates apassageway from the cavity into the interior of the patient. The methodfurther includes mating a connector to a proximal end of a catheter andinserting a distal end of the catheter through the second opening. Themethod further includes sliding the catheter through the second openinginto the interior of the patient and coupling the proximal end of thecatheter and the connector to the second opening thereby disposing theconnector substantially within the cavity and sealing the second openingand creating a fluid path from the interior of the patient to theconnector. The method further includes connecting a first deviceexternal to the patient to the connector through the first opening.

[0015] In one embodiment, the method further includes anchoring thehousing within the patient with sutures. The sutures includesubcutaneous sutures

[0016] In another embodiment, the method further includes anchoring thehousing within the patient with subcutaneous hooks.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

[0018]FIG. 1 is an illustrative perspective side view of a percutaneousaccess device according to one embodiment of the invention.

[0019]FIG. 2 is an illustrative top view of the percutaneous accessdevice shown in FIG. 1.

[0020]FIG. 3 is an illustrative perspective view of the percutaneousaccess device shown in FIG. 1.

[0021]FIG. 4 is an illustrative perspective front view of thepercutaneous access device shown in FIG. 1.

[0022]FIG. 5 is an illustrative cross-sectional side view of apercutaneous access device according to another embodiment of theinvention.

[0023]FIG. 6 is an illustrative cross-sectional side view of thepercutaneous access device of FIG. 5, implanted in a patient.

[0024]FIG. 7 is an illustrative cross-sectional side view of thepercutaneous access device shown in FIG. 5, implanted in a patient andconnected to an external medical device.

[0025]FIG. 8A is an illustrative cross-sectional view of aconnector-catheter connection including a valve in a closed positionaccording to one embodiment of the invention.

[0026]FIG. 8B is an illustrative cross-sectional view of theconnector-catheter connection shown in FIG. 8A, including the valve inan open position.

[0027]FIG. 9A is an illustrative cross-sectional view of a percutaneousaccess device including a pivoting luer connector in an open position,according to one embodiment of the invention.

[0028]FIG. 9B is an illustrative cross-sectional view of thepercutaneous access device shown in FIG. 9A, with the pivoting luerconnector in a closed position.

[0029]FIG. 10A is an illustrative cross-section view of a percutaneousaccess device including a telescopic luer connector in an extendedposition, according to one embodiment of the invention.

[0030]FIG. 10B is an illustrative cross-section view of a percutaneousaccess device including a telescopic luer connector in a retractedposition, according to one embodiment of the invention.

[0031]FIG. 11 is an illustrative top view of a percutaneous accessdevice according to another embodiment of the invention.

[0032]FIG. 12 is an illustrative cross-sectional side view of thepercutaneous access device of FIG. 11.

[0033]FIG. 13 is an illustrative top view of the percutaneous accessdevice including two connectors, according to another embodiment of theinvention.

[0034]FIG. 14 is an illustrative cross-sectional side view of thepercutaneous access device shown in FIG. 11, implanted in a patient andconnected to internally-implanted medical devices.

[0035]FIG. 15A is an illustrative top view of a housing cover, accordingto one embodiment of the invention.

[0036]FIG. 15B is an illustrative cross-sectional side view of a housingincluding the housing cover shown in FIG. 15A.

[0037]FIG. 16A is an illustrative diagram of a percutaneous accessdevice implanted in a patient and connected to internal and externalmedical devices, according to one embodiment of the invention.

[0038]FIG. 16B is an illustrative diagram of the percutaneous accessdevice shown in FIG. 16A, implanted in a patient and connected tointernal medical devices.

[0039]FIG. 17A is an illustrative top view of a housing cover with anelliptical shape, according to one embodiment of the invention.

[0040]FIG. 17B is an illustrative top view of a housing cover with ancanoe shape, according to another embodiment of the invention.

[0041]FIG. 17C is an illustrative top view of a housing cover with analmond shape, according to yet another embodiment of the invention.

DESCRIPTION

[0042] The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.In one embodiment, an access device allows physicians and/or othermedical personnel to obtain long term percutaneous access to theinterior of a patient's body. The access device reduces the opportunityfor infection by completely shielding fluid connections (that extendinto the interior of the patient's body) from the patient's skin andfrom the external environment. The access device has no protrudingexternal elements, and can be protected by a low-profile cover that issubstantially flush with the patient's skin. The access device thus iscosmetically appealing and allows substantially normal physicalactivity. The cover is difficult to remove accidentally or intentionallyfrom the access device. The access device allows access to the interiorof the patient without requiring a needle to pierce the skin. Further,internal components, such as a catheter or a valve, can be replacedwithout a surgical procedure.

[0043] Referring to FIGS. 1-4, in one embodiment, a medical device forallowing percutaneous access to a patient's body is an access device 100which includes a housing 112, a cavity 110, a first opening 116, aflange 102, a second opening 114, and a connector 104. The housing 112defines the cavity 110, the first opening 116 (which leads into thecavity 110), and the second opening 114 (which also leads into thecavity 110).

[0044] The housing 112 is implanted in a patient to dispose the cavity110 subcutaneously within the patient. After the housing 112 isimplanted in the patient, the first opening 116 is substantially flushwith the surface of the skin of the patient and creates a percutaneouspassageway from the exterior of the skin of the patient into the cavity110. The second opening 114 creates a passageway from the cavity 110into the interior of the patient. The connector 104 is coupled to thesecond opening 114 and is disposed substantially within the cavity 110.The connector 104 allows a first device which is external to thepatient, such as an infusion pump for example, to be connected to asecond device disposed within the interior of the patient, such as acatheter 106 for example. The flange 102, which is coupled to thehousing 112, holds the housing 112 in place once the housing 112 isimplanted in a patient. In one embodiment, the housing 112 is made of abio-compatible material such as Polysulfone or Titanium. The housing 112can also be made of a molded bio-compatible plastic material. In anotherembodiment, the housing 112 can made of a soft material that can bepenetrated by sutures or needles. In some embodiments, the housing 112is canoe shaped, elliptically shaped, or almond shaped, as indicated inFIGS. 17A, 17B, and 17C. In other embodiment, the housing 112 includes aconcave bottom, as indicated in FIG. 5 and in still other embodimentsthe housing 112 include a flat bottom, as indicated in FIG. 1.

[0045] Referring to FIG. 5, in one embodiment, the connector 104 is aluer connector and is coupled to the second opening 114 and the catheter106. A proximal end 516 of the catheter 106 is first positioned over adistal end 506 of the connector 104. The catheter is held in place overthe connector 104 by a plurality of barbs 504 (or a raised ring) on thedistal end 506 of the connector 104. The distal end 506 of the catheter106 is fed through the opening 114 until the plurality of barbs 504 onthe distal end 506 of the connector 104 engage a plurality of barbs 512within the second opening 14. The connector 104 is secured in place byengaging the plurality of barbs 504 with the plurality of barbs 512.After the connector 104 is secured in place, the connector 104 ispositioned such that the connector 104 is disposed substantially withinthe cavity 110. Specifically, in some embodiments, a small portion ofthe connector 104 can extend out of the first opening 116. However, inother embodiments, no portion of the connector 104 extends out of thefirst opening 116 and is disposed entirely within the cavity 110. Insome embodiments, the connector 106 is sealable when not in use. Forexample, the connector 106 can have a threaded or friction fit sealingcap that is removed during use and replaced when not in use. The cap canalso include a penetrable surface, such as rubber or silicone forexample, which can be penetrated by a needle. Further, the connector 106can include a valve 518 which opens when the connector 106 is connectedto an external device and closes when the connector 106 is disconnectedfrom the external device. In some embodiments, the value 518 can be aslit valve made of foam or rubber. The connector 106 is also compatiblewith typical medical luer attachments. In other embodiments, theconnector 104 and the catheter 106 can include a single lumen ormultiple lumens.

[0046] Referring to FIGS. 1 and 6, in one embodiment, the percutaneousaccess device 100 is implanted into a patient 604 as follows. First, alinear incision is made in the patient. Such an incision is lesstraumatic to the patient (as opposed to coring). A distal end of aguidewire is inserted through the incision, into the patient 604, andinto an area in which the catheter 106 is to be placed, such as vein forexample. If necessary, a dilator may be placed over the guidewire todilate the area where the catheter 106 is to be inserted. A proximal endof the guidewire is inserted through the second opening 114 and thehousing 112 is then inserted into the patient 604 through the incision.The housing 112 is positioned so that the second opening 114 is axiallyaligned with the guidewire, the flange 102 is subcutaneous, and thefirst opening 116 is substantially flush with the surface of thepatient's skin 604. The flange 102 promotes stability of the housing 112and adhesion of the skin and subdermal layers immediately adjacent tothe incision site. In some embodiments, subcutaneous sutures sewnthrough holes in the flange 102 can be used to anchor the subdermallayers to the flange 102. In other embodiments subcutaneous hooks may beused to anchor the subdermal layers to the flange 102. In still otherembodiments, the flange 102 can be coated with materials that promotetissue growth to provide better sealing of the incision, such ascollagen or other tissue growth catalysts, for example. Materials thatpromote ingrowth of cells, such as a permeable fabric, a texturedpolymer, or a steel mesh can also be bonded to or embedded in the flange102. The added ingrowth materials cause the skin surrounding the flange102 to bond securely with the flange 102. The surface of the patient'sskin 604 may also be secured to the housing 112 by using glue, such asDermabond (a trademark of and a product commercially available fromClosure Medical Corporation of Raleigh, N.C.) or medical tape around theincision site.

[0047] After the housing 112 is anchored in place, the distal end 514 ofthe catheter 106 is inserted through the second opening 114 over theguidewire and fed into the patient. Next, the guidewire is removed andthe proximal end 516 of the catheter 106 is coupled to the distal end506 of the connector 104 and the distal end 506 of the connector 104 isfed through the opening 114 and secured in place (as previouslydescribed) thereby sealing the opening 114 and creating a fluid path 502from the interior of the patient to the connector 104.

[0048] The implanted access device 100 can then be covered with atemporary dressing or Tegaderm (a trademark of and a productcommercially available from 3M Health Care Ltd. of Loughborough, UK)which is a skin-like bandage. The cavity 110 can also be filed withgauze and/or antimicrobial agents. In another embodiment, the housing112 can be covered with a low-profile, housing cover 602, which can beshaped to conform to the contour of the patient's skin. The housingcover 602 couples to an edge 108 of the housing 112 and creates awatertight seal and protects the connector 106 and the cavity 110 fromdebris and damage from the environment. In some embodiments, the housingcover 602 includes a locking mechanism which prevents the housing cover602 from being accidentally or intentionally removed by the patient. Forexample, the housing cover 602 can be secured to the housing 112 byusing a friction fit or a thread fit. The housing cover 602 can also besecured to the housing 112 using clamps that clamp onto the edge 108.The clamps can be configured to selectively engage and disengage theedge 108 when a key is inserted into the housing cover and turned. Inother embodiments, the housing cover 602 can be coupled to the housing112 with a wire or a hinge, for example. Additionally, gauze can beplaced around the first opening 116 between the patient's skin and thehousing cover 602.

[0049] In another embodiment, after the linear incision is made, theguidewire is inserted into the vein (or other organ) and then the distalend 514 of the catheter 106 is inserted into the vein over theguidewire. Next, the proximal end 516 of the catheter is inserted intothe second opening 14 and fed into the housing 112. The guidewire isremoved and the distal end 506 of the connector 104 is then coupled tothe proximal end 516 of the catheter and then fed through the opening114 and secured. The housing 112 is then implanted into the patientusing the procedure previously described.

[0050] Referring to FIGS. 6 and 7, the connector 104 is accessed byfirst removing the housing cover 602. Next, an external medical device,such as a connection tube 702 to an infusion pump, is connected to theconnector 104 creating a fluid connection 502 through opening 118. Afterthe procedure utilizing the infusion pump has been completed, theconnection tube 702 is disconnected from the connector 104 and thehousing cover 602 is placed back on the housing 112 to seal the cavity110 and protect the connector 104. The access device 100 can be usedwith a variety of other medical devices, such as body fluid removaldevices and blood purification devices, for example.

[0051] The access device 100, after initial surgical implantation,enables physicians and/or other medical personnel to repeatedly (andwithout further surgery) access various internal regions of the patient,such as veins, arteries, and various organs for example. The connector104 and fluid connection that extends into the patient's body isshielded from the patient's skin and from the external environment, andthereby reduces opportunity for infection. The access device 100 has noprotruding external elements, and can be protected by the low-profilehousing cover 602 which is substantially flush with the patient's skinand thereby allows the patient to engage in substantially normalphysical activity.

[0052] Referring again to FIGS. 5 and 6, if the access device 100remains implanted for an extended period of time, the connector 104and/or the catheter 106 may need to be replaced. Replacement of thesecomponents can be achieved without surgery. First, the housing cover 602is removed from the housing 112. Next, the connector 104 is removed fromthe second opening 114 and the connector 104 is decoupled from thecatheter 106. A guidewire is fed through the catheter into the patient.The catheter 106 is then removed from the patient. A new catheter 106 isinserted into the patient over the guidewire through the second opening114 and the guidewire is then removed. A new connector 104 is coupled tothe catheter 106 and secured in the second opening 114 as previouslydescribed. A benefit of this feature is that the connector 104 and/orthe catheter 106 can be replaced without surgery, resulting in lesstrauma to the patient and reduced chance of infection.

[0053] Referring to FIGS. 8A and 8B, in another embodiment, theconnector 104 is a luer connector and is coupled to the second opening114 and the catheter 106. A proximal end 516 of the catheter 106 isfirst positioned over a distal end 506 of the connector 104. Thecatheter 106 is held in place over the connector 104 by a plurality ofbarbs 804 (or a rings) on the distal end 506 of the connector 104. Thedistal end of the catheter 106 is fed through the opening 114 until theplurality of barbs 504 on the distal end 506 of the connector 104 meet aplurality of O-rings 802. The connector 104 is secured in place byengaging the plurality of barbs 504 with the plurality of O-ring 802.After the connector 104 is secured in place, the connector 104 ispositioned such that the entire connector 104 is disposed entirelywithin the cavity 110. The connector 104 also includes a threadedlocking cap 808 which engages threads 806. The locking cap 808 is usedto secure a connection between the connector 104 and an external medicaldevice. The connector 104 can also include a valve 810 which remainssealed when no external medical device is connected to the connector 104and opens when the connector 104 is connected to an external medicaldevice, such as a connection tube 812 to an infusion pump.

[0054] Referring to FIGS. 9A and 9B, in another embodiment, the accessdevice 100 includes a pivoting luer connector 902. The pivoting luerconnector 902, when pivoted to a first position, opens the fluid path502 through the second opening 114 and, when pivoted to a secondposition, closes the fluid path 502 through the second opening 114. Inoperation, when the pivoting luer connector 902 is not in use, thepivoting luer connector 902 is pivoted to the second position therebykeeping the fluid path 502 closed. The pivoting luer connector 902 isonly pivoted to the first position after an external medical device hasbeen connected to the pivoting connector 902.

[0055] Referring to FIGS. 10A and 10B, in still another embodiment, theaccess device 100 includes a telescopic luer connector 1002. Thetelescopic connector 1002, when not in use, is disposed entirely withinthe cavity 110. However, when the telescopic connector 1002 is in use,the telescopic connector 1002 can be extended out of the cavity 110 toallow a physician or other medical personnel to connect an externalmedical device more easily. In another embodiment, the telescopicconnector 1002 includes a stop or plug disposed inside the connector1002. The stop is coaxial with the opening 118 and acts as a valve whichseals the opening 118 when the telescopic connector is 1002 isretracted. When the telescopic connector 1002 is extended, the sealbetween the opening 118 and the stop is broken thereby allowing fluid toflow past the stop and through the opening 118.

[0056] Referring to FIG. 13, in other embodiments, the access device 100includes two luer connectors 1304 a and 1304 b and two correspondingcatheters 1302 a and 1302 b. In this configuration, blood, for example,can be easily drawn out of a patient, purified, and put back into thepatient. In another embodiment, the access device 100 includes two luerconnections that both connect to a single catheter. The single cathetera single lumen catheter or multilumen catheter.

[0057] In other embodiment, the access device 100 includes a luerconnector with a pressure-responsive slit valve. The valve includes adiaphragm including a slit which is flexed in one direction byhydrostatic pressure and flexed in an opposite direction by negativepressure to selectively open the slit. Examples of such apressure-responsive slit valves are shown in U.S. Pat. No. 5,205,834,U.S. Pat. No. 5,201,722, and U.S. Pat. No. 5,169,393 which are hereinincorporated by reference.

[0058] Referring to FIGS. 11, 12, and 14, in another embodiment, thecavity 110 of the access device 100 is used to store a small printedcircuit board 1102 including electronics 1108 and/or a battery 1106 usedin conjunction with one or more medical devices implanted in a patient,such as a pacemaker 1402 and/or a sensor 1404, for example. In thisconfiguration, the connector 104 is an electrical connector. Theconnector 104 is positioned such that the connector 104 is disposedsubstantially within the cavity 110. Specifically, in some embodiments,a small portion of the connector 104 can extend out of the first opening116. However, in other embodiments, no portion of the connector 104extends out of the first opening 116 and is disposed entirely within thecavity 110.

[0059] Wires (or optical fiber) 1202 from the connector 104 extendsubcutaneously from the housing 112 and connect to the pacemaker 1402and/or sensor 1404. Wires (or optical fiber) 1104 extending from theconnector 104 inside the cavity 110 connect to a connector 1110 on theprinted circuit board 1102. The printed circuit bard 1102 is coupled tothe housing 112 inside the cavity 110 by mounting posts 1204.

[0060] Referring to FIG. 16B, in one embodiment, an infusion pump 1616and a medication reservoir 1618 can be housed in the cavity 110 of theaccess device 100. The medication reservoir 1618 supplies medication tothe infusion pump 1616 through tube 1620. The infusion pump 1616 pumpsmedication though tube 1622, through luer connector 1626, and throughcatheter 1628 and into the patient's body 604. Electronics 1614 (housedin the cavity 110) can include a battery to power the infusion pump 1616and control circuitry to control the infusion pump 1616. In addition tothe luer connector 1626, the access device 100 can also include one ormore electronic connectors, such as electrical connector 1630.Electronic connector 1630 can be used to connect power and controlelectronics to a sensor 1624, or other device (via wires or opticalfiber 1626) implanted in the patient, for example. In anotherembodiment, the entire cavity 110 can be used as a medication reservoir.

[0061] Referring to FIG. 14, in another embodiment, the printed circuitboard 1102 (housed in the cavity 110) can include control circuitry 1108and a battery 110 to control and power a pacemaker 1402 implanted in apatient's body 604. In this configuration, the battery 1110 can bereplaced without surgery by simply removing the housing cover 602,replacing the battery 1110, and then replacing the cover 602. Similarly,the electronics 1108 controlling the pacemaker 1402 can also be repairedand/or adjusted with surgery. In other embodiments, the wires 1202extending into the patent's body 604, can fan out to connect to multiplemedical devices such as the pacemaker 1402 and one or more sensors 1404.In still other embodiments, the access device 100 can include multipleelectronic connectors 104.

[0062] As previously described, the electronics 1108 on the printedcircuit board 1102 can include control and memory electronics forvarious sensors, such as pressure sensors and urine pH sensors forexample. In another embodiment, these sensors (along with controlcircuitry and power) can be housed in the cavity 100, and the fluid tobe analyzed (blood or urine, for example) is brought into the cavity 100via an inlet luer connector and pumped back into the body via an outletluer connector.

[0063] Referring to FIG. 16A, in still another embodiment, the accesshousing 100 can include any combination of connectors. For example, theaccess housing 100 can include an inlet luer connector 1638 and anoutlet luer connector 1636. The inlet connector 1638 is connected to acatheter 1632 which is also connected to a vein 1602. The outletconnector 1636 is connected to a catheter 1634 which is also connectedto the vein 1602. The inlet connector 1638 is also connected to tube1606 which is connected to a blood purification device 1608 external tothe patient 604. The outlet connector 1636 is also connected to a tube1604 which is also connected to the blood purification device 1608. Inoperation, the blood purification device 1608 draws blood through thecatheter 1632, through the inlet connector 1638, through the tube 1606and into the blood purification device. After the blood is purified, theblood purification device 1608 pumps the purified blood through tube1604, through outlet connector 1636, through catheter 1634 and back intothe vein 1602. Further, the access device 100 can include an electronicconnector 1640 which connects control and power electronics 1612 to amedical device (via wires or optical fiber 1642) such as a blood presssensor 1610 implanted in the patient 604.

[0064] In another embodiment, the cavity 110 of the access device 100can be configured to house various electromechanical components of anartificial heart implanted in a patient. In this embodiment, theelectromechanical parts are accessible (without requiring surgery) byremoving the housing cover 602.

[0065] In other embodiments, the access device 100 can includeelectronics capable of wireless communication. In this embodiment,physicians and/or medical personnel can wirelessly communicate withelectronics stored in the cavity 110 (without removing the cover 602) todownload data from various sensors implanted in a patient, for example.The physician can also download a status of a medication reservoir or astatus of battery power. Further, the electronics housed in the cavityused to communicate with and control various implanted medical devicescan do so wirelessly. For example, a sensor used for sensing thepressure in a particular artery can transmit sensor data wirelessly toan electronic storage element in the cavity 110, or control circuitryused for controlling a pacemaker can transmit control signals wirelesslyto the pacemaker.

[0066] In another embodiment, sensor signals can be transmitted througha fluid. For example, a pressure sensor is housed within the cavity 110.The sensor is in physical communication with a proximal portion of anelongated membrane that contains a fluid. The elongated membrane extendsoutside the cavity 110 into the interior of the patient. A pressurechange in the patient causes pressure on a distal portion of themembrane which, in turn, causes the fluid within the membrane to flowback to the proximal portion of the membrane and be detected by thepressure sensor.

[0067] Referring to FIGS. 15A and 15B, in another embodiment, thehousing cover 602 can include low-profile electronic connectors 1506and/or fiber optics connectors 1508 which can be used to access and readout sensor data stored in a memory chip on the printed circuit board1102 without having to remove the housing cover 602. The housing cover602 can also include a low-profile luer connector 1510 which enables afluid connection to the cavity 110. Such a fluid connection enables aphysician and/or medical personnel to access a medical device implantedin the patient (through the cavity 110) or refill a medication reservoirwithin the cavity 110 without having to remove the housing cover 602.Further, the housing cover 602 can also include indicator LEDs 1502 toindicate low battery power or low medication reservoir levels, forexample. The housing cover 602 can also include a battery connector 1502to enable recharging of a battery 1110 stored in the cavity 110 withouthaving to remove the cover 602. The housing cover 602 can also include alow-profile liquid crystal or LED display for reading sensor data,providing a status of battery power, or providing a status of amedication reservoir stored in the cavity 110, for example. Moreover,the housing cover 602 can include an infrared or wireless communicationport 1514 to allow wireless communication with electronics stored withinthe cavity 110 and/or medical devices implanted in the patient.

[0068] Some of the benefits of utilizing the access device 100 to storesuch electronics and/or batteries include nonsurgical accessibility ofthe electronics for repair and/or replacement, nonsurgical batteryreplacement, patient comfort, and reduced chance of infection fromelectronic components.

[0069] Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention.Accordingly, the invention is not to be defined solely by the precedingillustrative description.

What is claimed is: 1-29. (Cancelled).
 30. An access port forimplantation into a patient, comprising: a housing defining a cavitytherein, the housing including a first opening extending from anexterior of the housing to the cavity and a second opening extendingfrom an exterior of the housing to the cavity wherein, when implanted inthe body in an operative position, the first opening faces a skin of thepatient and the second opening faces away from the skin toward aninterior of the patient; a removable connector including a distal endsized to be received within an access device, the removable connectorincluding a locking element which, when the removable connector isreceived within the second opening, locks the removable connector to thehousing.
 31. The access port according to claim 30, further comprising acover sealing the first opening when access to the access device is notdesired.
 32. The access port according to claim 31, wherein the cover isshaped to substantially conform to a shape of a portion of skinsurrounding the first opening.
 33. The access port according to claim30, wherein the removable connector comprises a connection tube.
 34. Theaccess port according to claim 30, wherein the locking element includesat least one projection which mates with a corresponding projection on asurface of the housing adjacent to the second opening.
 35. The accessport according to claim 30, wherein the removable connector furthercomprises a cap selectively opening and closing an opening of theremovable connector.
 36. The access port according to claim 30, whereinthe removable connector is telescopic for extension out of the cavity toestablish access to the access device.
 37. The access port according toclaim 31, wherein the cap includes a lock for locking the cap in placeon the housing.
 38. The access port according to claim 30, wherein thehousing is substantially elliptical.
 39. The access port according toclaim 30, wherein the removable connector includes a valve and anextension portion wherein, when the valve is in a first position, alumen of the valve is aligned with a lumen of the extension portion and,when in a second position, the lumen of the valve is sealed from thelumen of the extension portion.
 40. The access port according to claim39, wherein the valve pivots between the first and second positions. 41.A method of accessing areas within a patient's skin, comprising: makingan incision through the patient's skin; implanting through the incisiona port with a cavity formed therein, the port including a first openingextending from an exterior thereof to the cavity and a second openingextending from an exterior thereof to the cavity, the port beingimplanted so that the first opening faces the skin and the secondopening faces away from the skin toward an interior of the patient; andinserting into the second opening a connector adapted to couple to anaccess device.
 42. The method according to claim 41, wherein theincision is a substantially straight incision.
 43. The method accordingto claim 41, further comprising the step of locking the connector to theport.
 44. The method according to claim 43, wherein the connector islocked to the port by engaging a projection on the connector with acorresponding projection on the port.